JOB RESPONSIBILITIES:Formulated Solutions is seeking a Manager, Corporate Regulatory, Compliance & Supplier Quality. This position is responsible for managing and supporting enterprise-wide regulatory, compliance, and supplier quality programs across Formulated Solutions. The Manager ensures applicable regulatory, cGMP, customer, contractual, and company requirements are consistently implemented, monitored, and maintained through effective quality-system and supplier controls across company sites.
Reporting to the VP of Quality, this position provides day-to-day leadership to direct reports assigned to Regulatory, Compliance and Supplier Quality activities. The Manager partners with Quality Assurance, Regulatory Affairs, Quality Control, Operations, Supply Chain, Procurement, Innovation and Development (InD), Analytical Research and Development (AR/D), Product Development, Commercial, and site leadership to support inspection readiness, supplier qualification and monitoring, compliance assessments, quality-system improvement, performance metrics, and timely escalation of significant risks.
ESSENTIAL DUTIES AND RESPONSIBILITIES:- Corporate Regulatory & Compliance
- Manage the day-to-day execution and maintenance of enterprise compliance activities across Formulated Solutions locations.
- Support implementation and maintenance of enterprise compliance standards, procedures, and supporting controls.
- Support translation of applicable regulatory, cGMP, customer, and contractual requirements into practical business and quality-system expectations.
- Identify compliance risks and support development and tracking of risk-based remediation actions.
- Partner with site Quality organizations to promote consistent interpretation and execution of established company compliance requirements.
- Support FDA, customer, and other regulatory or quality-system inspections, audits, and inspection-readiness activities.
- Participate in investigations, CAPAs, change controls, risk assessments, management reviews, and remediation initiatives as assigned.
- Review recurring deviations, audit findings, CAPAs, and quality events for systemic or cross-site trends and escalate significant concerns.
- Maintain enterprise compliance metrics and dashboards and provide routine reporting of significant risks, trends, and remediation status to Quality leadership.
- Monitor applicable regulatory and industry developments and coordinate assessment of potential business and quality-system impact.
- Monitor applicable USP/NF and other recognized compendial updates and coordinate assessment of potential impact to materials, specifications, test methods, Inspection Records, and quality-system requirements.
- Partner with Quality Control, Regulatory Affairs, Supplier Quality, and Technical functions to ensure applicable compendial changes are evaluated, documented, implemented within required timelines, and escalated when gaps or delays are identified.
- Responsible for oversight of site registrations and certifications, including coordination of required renewals and ongoing maintenance to ensure registrations and certifications remain current and in good standing.
- Support responses to regulatory observations, customer findings, and significant compliance issues.
- Support or coordinate enterprise compliance assessments and internal audits as assigned.
- Track assigned compliance commitments and remediation actions through completion and effectiveness evaluation.
- Supplier Quality
- Manage execution and maintenance of the enterprise Supplier Quality program.
- Coordinate risk-based supplier qualification, approval, monitoring, requalification, and disqualification activities in accordance with established procedures.
- Support risk-based supplier categorization and ensure assigned supplier controls are proportionate to material, service, product, regulatory, and business risk.
- Coordinate and participate in supplier audits, supplier quality assessments, and supplier corrective-action processes.
- Manage supplier corrective actions and track significant supplier CAPAs through closure and effectiveness evaluation when applicable.
- Maintain supplier performance-monitoring activities and enterprise supplier-quality metrics.
- Coordinate Quality Agreement development, review, maintenance, and related supplier-quality requirements within the assigned scope.
- Partner with Procurement, Supply Chain, Quality, Regulatory Affairs, Operations, and Technical functions during supplier selection, onboarding, and changes.
- Ensure supplier changes and notifications are appropriately routed for assessment of quality, regulatory, technical, and customer impact.
- Monitor and escalate supplier risks affecting product quality, compliance, continuity of supply, or customer requirements.
- Support recommendations regarding supplier approval, conditional approval, restriction, suspension, or disqualification based on documented risk and performance.
- Coordinate periodic supplier performance reviews and escalation of recurring supplier issues.
- Support supplier improvement initiatives and standardization of Supplier Quality practices across company sites.
- Quality System Integration
- Partner with Quality Assurance and Regulatory Affairs to ensure applicable regulatory and compliance requirements are incorporated into quality systems and operating processes.
- Participate in investigations, CAPAs, change controls, risk assessments, and management-review activities where enterprise or supplier-quality impact exists.
- Assess compliance implications associated with significant supplier, process, system, organizational, and regulatory changes.
- Support implementation of policies and systems applicable to OTC drugs, cosmetics, pharmaceutical products, medical devices, and other regulated product categories within the company portfolio.
- Support remediation activities arising from FDA inspections, customer audits, internal audits, regulatory assessments, and quality-system reviews.
- People Leadership
- Directly supervise, coach, and develop direct reports assigned to Regulatory, Compliance and Supplier Quality responsibilities.
- Establish daily and short-term priorities, accountability, and performance expectations for assigned personnel and programs.
- Coordinate workload and resource priorities based on compliance, supplier, customer, and business risk.
- Support employee development, cross-training, and functional capability within assigned areas.
- Ensure direct reports understand applicable procedures, responsibilities, escalation expectations, and have appropriate tools and resources to execute assigned work.
- Coordinate or participate in cross-functional initiatives involving multiple sites or departments.
- Promote timely identification and escalation of quality and compliance risks and foster collaboration across Quality, Regulatory Affairs, Supply Chain, Procurement, Operations, Commercial, and Technical functions.
- Metrics & Performance Management
- Maintain and report metrics for supplier qualification and requalification, supplier audits, supplier CAPA aging and effectiveness, supplier change notifications, and supplier risk and performance trends.
- Maintain and report compliance metrics for audit and inspection observations, CAPA aging and recurrence, repeat deviations, remediation-plan status, inspection readiness, and significant compliance-risk trends.
- Use metrics and trend analysis to identify adverse trends, support prioritization, and escalate significant concerns to Quality leadership.
- Decision Authority
- Manage assigned Regulatory, Compliance and Supplier Quality activities in accordance with established procedures and delegated authority.
- Support or recommend supplier qualification and monitoring strategies within established procedures.
- Recommend supplier approval, conditional approval, restriction, suspension, or disqualification based on documented risk.
- Require follow-up or corrective action within delegated authority when assigned compliance or supplier-quality requirements are not adequately met.
- Escalate significant or systemic compliance and supplier-quality risks to the VP of Quality or designated Quality leadership.
- Recommend additional controls or temporary restrictions when documented risk warrants further action.
- Assign and prioritize work within assigned Regulatory, Compliance and Supplier Quality activities.
- Other duties as assigned
CRITICAL SKILLS AND ABILITIES:- Strong working knowledge of cGMP requirements, regulated quality systems, and risk-management principles.
- Strong knowledge of supplier quality management, including qualification, auditing, supplier corrective actions, Quality Agreements, change management, and supplier performance monitoring.
- Ability to identify patterns across events, suppliers, sites, or processes and recommend practical solutions.
- Ability to evaluate quality, technical, regulatory, supplier, contractual, and operational information and reach clear, documented conclusions.
- Ability to balance compliance, product quality, consumer or patient protection, customer commitments, business continuity, and operational practicality without compromising applicable requirements.
- Demonstrated people leadership, including setting expectations, assigning work, coaching employees, and addressing performance gaps.
- Ability to influence and work effectively with cross-functional teams across multiple locations.
- Excellent written, verbal, presentation, project-management, and organizational skills.
- Ability to maintain meaningful metrics, analyze trends, identify risk, and communicate actionable information to Quality leadership.
- High degree of professional integrity, discretion, objectivity, and willingness to escalate significant compliance or supplier-quality concerns.
EDUCATION AND EXPERIENCE:- Bachelor's degree in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Biology, Engineering, Quality, or a related scientific or technical discipline required.
- Minimum 7-10 years of progressive experience in Regulatory Affairs and Quality Compliance within FDA-regulated industries.
- Prior supervisory or team-lead experience with responsibility for direct reports strongly preferred.
- Demonstrated experience supporting FDA or other regulatory inspections, customer audits, internal audits, investigations, CAPAs, and change controls.
- Prior experience in a CDMO/CMO, pharmaceutical, or other FDA-regulated manufacturing organization strongly preferred.
- Advanced degree and/or professional certification such as RAC, ASQ Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or comparable certification preferred.
- Experience with eQMS, supplier-management, document-management, regulatory-information, and data-analytics systems preferred.
